SEPSIS
Conditions
Brief summary
The study primary endpoint is the decrease of SOFA score by the end-of-treatment (EOT). This is defined as either a) at least 1.4 points decrease of mean SOFA score calculated between days 1 and EOT from SOFA score of day 0; OR b) at least 2 points decrease of SOFA at EOT from day 0., Patients dying before the EOT are considered not meeting the primary endpoint. EOT is defined as the day of end of treatment of the study drug for each of the study participants. For patients requiring dosing by day 27, the decrease of the SOFA score is evaluated on day 28.
Detailed description
The number of doses required in each group to achieve the SOFA score response by the EOT, 28-day mortality
Interventions
Sponsors
Hellenic Institute For The Study Of Sepsis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study primary endpoint is the decrease of SOFA score by the end-of-treatment (EOT). This is defined as either a) at least 1.4 points decrease of mean SOFA score calculated between days 1 and EOT from SOFA score of day 0; OR b) at least 2 points decrease of SOFA at EOT from day 0., Patients dying before the EOT are considered not meeting the primary endpoint. EOT is defined as the day of end of treatment of the study drug for each of the study participants. For patients requiring dosing by day 27, the decrease of the SOFA score is evaluated on day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of doses required in each group to achieve the SOFA score response by the EOT, 28-day mortality | — |
Countries
Greece
Outcome results
None listed